Shivani Patel

- Managing the new product line and collaborate with the company’s cross functional team to bring the new product line within technical, clinical and market applicable standards.

- Liaise with cross-functional departments for preparation of documentation necessary for submission of applications (MDD to MDR) to EU Notify Body.

- Review data from contributing departments and provide comments to ensure accurate and complete documents for inclusion in the applicable regulatory standards (UDI, IFU, Labeling, Packaging, Marketing). Serve as a key member of the matrix regulatory team including generation of meeting agenda and minutes. Contribute to the generation and review of regulatory strategy documents.

- Independently manage interactions with clinical monitors, data management, safety, regulatory, and QA team members, both internally and externally in mitigations to the product release.

- Work with departmental leaderships to maintain and continuously improve an EN ISO 9001 current version, ISO 13485, EN ISO 60601 versions and others.

- Participate in the Corrective Action and Preventive Action (CAPA) Review Board, internal and external audits, and training program. Make recommendations for corrective action necessary to ensure conformity with quality specifications.

- Document and implement end of life procedure, plan and reports (discontinue medical device).

• Evaluate upcoming regulatory changes and communicate the impact on products and processes with cross-functional teams.
• Technical reviews of the technical files required for CE Mark before its submission to Notified Bodies.
• Lead external audits (EU MDR, ISO 13485, MDSAP) and guarantee manufacturer's adherence to stipulated requirements.
• Lead internal quality audits (EU MDR, ISO 13485, MDSAP), identify areas for enhancement, and drive initiatives for continuous quality improvement.
• Interact with regulatory agencies, internal, and external stakeholders to facilitate product registrations, submissions, and approvals.
• Manage and host regulatory inspections, ensuring the company is always inspection-ready
• Lead, mentor, and expand the Quality team spanning both QA and QMS functions. Providing compliance guidance to employees on a daily basis.
• Oversee the development, implementation, and maintenance of the Quality Management System projects.
• Handling of adverse event, reporting to regulatory bodies and other involved stakeholders, planning and implementing corrective and preventive actions.

• Perform critical review of Technical file before submitting it to notified bodies to ensure compliance with EU MDR.
• Perform critical review of QMS documentation before submitting it to notified bodies to ensure compliance with ISO 13485, 21 CFR 820, MDSAP etc.
• Provide regulatory input for and appropriate follow-up to inspections and audits.
• To evaluate and respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.
• Co-ordination with external testing laboratory on behalf of clients.
• Project Lead of team to perform CE, MDSAP and ISO 13485 audit preparation & support on-site and off-site.
• Communication with Notified bodies/ regulatory authorities for resolution of non-conformities and adverse events.

• Preparation of technical file as per EU MDD for Orthopedic implants, Disposable devices, ENT devices.
• EU MDR Technical File Preparation for active devices, non-active devices like surgical dressing, surgical and examination gloves.
• Prepare, review and update QMS procedures as per ISO 13485.
• Implementation of QMS in multiple manufacturing units.
• Risk management as per ISO 14971, documentation and implementation.
• Country-specific registration document dossiers and submissions.
• Blog-writing on regulatory hot-topics

• Preparation of technical file as per EU MDD for Orthopedic implants, Disposable devices, ENT devices
• Prepare, review and update QMS procedures as per ISO 13485.

• Responsible for providing support in maintaining CE Technical Documentation
• Preparation of Device Master File as per Indian Medical Device regulation, 2017.